Intended Use; General Safety Instructions - Ossur TOTAL KNEE 1900 Gebrauchsanweisung

ENGLISH
Medical Device
DESCRIPTION
The device is a polycentric knee joint with a Geometric Locking System,
and a unique swing phase control through the use of friction within an
elastic polymer medium.
Proximal adapter options are available, and the device has a Distal Tube
Connector.
Interchangeable Bumpers (Fig. 7A) allow for knee flexion to be adjusted
to suit the patient's preference and activity levels. The adjustable
Extension Promoter (7D) assists in limiting heel rise and moving the
device into a fully extended position.

INTENDED USE

The device is intended as a part of a prosthetic system that replaces knee
function of a missing lower limb.
Suitability of the device for the prosthesis and the patient must be
evaluated by a healthcare professional.
The device must be fitted and adjusted by a healthcare professional.
Indications For Use and Target Patient Population
• Lower limb amputation and/or congenital deficiency
• No known contraindications
The device is for low to moderate impact use, e.g., walking.
The weight limit for the device is 100 kg.

GENERAL SAFETY INSTRUCTIONS

The healthcare professional should inform the patient about everything
in this document that is required for safe use of this device.
Warning: If there is a change or loss in device functionality, or if the
device shows signs of damage or wear hindering its normal functions,
the patient should stop using the device and contact a healthcare
professional.
Warning: Avoid placing hands or fingers near moving joints.
Caution: Do not adjust other screws than described in these instructions.
The device is for single patient use.
ASSEMBLY INSTRUCTIONS
Warning: Risk of structural failure. Components from other
manufacturers have not been tested and may cause excessive load on the
device.
Proximal Adapter Options
The following proximal adapter options are available for the device (Fig. 1):
• 4-Prong Socket Adapter (1A),
• Female Pyramid Adapter (1B),
• Euro 4-Hole Adapter (1C), or
• Male Pyramid Adapter (1D).
Caution: Only use the specified Total Knee proximal adapters, please
refer to Össur catalogue for more information.
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